Cleared Traditional

K873519 - PARAMAX CALCIUM REAGENT

K873519 is the FDA 510(k) clearance for PARAMAX CALCIUM REAGENT by Baxter Healthcare Corp. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K873519 · Baxter Healthcare Corp · Chemistry device
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Dec 1987
Decision
104d
Days
Class 2
Risk

K873519 is an FDA 510(k) clearance for the PARAMAX CALCIUM REAGENT. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on December 14, 1987 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K873519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 1987
Decision Date December 14, 1987
Days to Decision 104 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 88d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIC Cresolphthalein Complexone, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CIC Cresolphthalein Complexone, Calcium

All 68
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K873519.
CALCIUM
K880308 · Catachem, Inc. · May 1988
CALCIUM, CATALOGUE NUMBER 122-20
K881054 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1988
CALCIUM ASSAY KIT, NUMBER 120-19
K874496 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K874131 · Pointe Scientific, Inc., · Dec 1987
WAKO(TM) AUTOKIT CALCIUM
K873334 · Wako Chemicals USA, Inc. · Oct 1987
CALCIUM REAGENT - CRESOLPHTHALEIN COMPLEXON METHOD
K870362 · Trace Scientific , Ltd. · Aug 1987